Validation Specialist

Stevanato Group; Piombino Dese; In loco; EUR 40.000 - 55.000; Tempo pieno

Descrizione del lavoro

A leading pharmaceutical manufacturer located in Piombino Dese is seeking a Validation Specialist for their Quality Assurance team. The role involves ensuring compliance with ISO and cGMP standards while executing validation processes. Candidates should have a Technical Master’s Degree and at least 2 years of relevant experience in pharmaceutical validation. This position offers a full-time employment with opportunities for career growth.

Competenze

• 2 years proven experience in Validation within quality pharmaceutical companies.
• Knowledge of applicable regulatory and standard manufacturing practices.
• Knowledge of Quality Management System processes and techniques.

Mansioni

• Execute the qualification and validation activities as per the approved plan.
• Support in defining qualification and validation activities.
• Provide timely and accurate validation documents.

Conoscenze

Validation experience in pharmaceutical companies

Knowledge of cGMP and ISO standards

Project Management

Analysis and Reporting skills

Formazione

Technical Master’s Degree

Descrizione del lavoro

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We are looking for a Validation Specialist – Quality to join our HQ team in Piombino Dese (Padova). The chosen candidate will be responsible to execute the qualification and validation processes assigned, maintain up-to-date tools, guidelines, and other procedures aimed at achieving reliability and compliance, in alignment with applicable standards such as ISO, CE, cGMP and other local requirements.

Key Responsibilities

• Executes the qualification and validation activities to achieve the validation targets according to the level of services and timing defined in the approved plan, guaranteeing compliance with applicable standards.
• Supports the leader in defining qualification and validation activities, ensuring the compliance of the quality management system with applicable standards and requirements.
• Provides timely and accurate validation documents, monitoring third‑party reports to be reviewed by the leader for final submission.
• Participates alongside the Commercial Team to carry out new projects, ensuring technical assistance and validation, and collaborates with the R&D Team to define processes that guarantee product quality and reliability.
• Contributes to cascading accurate and up‑to‑date information related to regulations, customer requirements, and other applicable standards to the team and other functions involved in the processes.
• Provides technical support to other functions to ensure full application of the relevant QMS for validation processes.
• Participates in audit sessions and customer technical meetings, providing accurate and timely technical services and support; executes corrective and preventive actions in close collaboration with involved teams.
• Elaborates appropriate reports to monitor KPIs related to validation, meeting internal and external needs, highlighting timely deviations and critical issues, and proposes actionable initiatives to the leader for effective resolution.
• Participates in assigned projects, providing the project team with delivered actions that enable synergy and efficiency across involved processes.

Qualifications

• 2 years proven experience in Validation within quality pharmaceutical companies.
• Technical Master’s Degree.
• Knowledge of applicable regulatory and standard manufacturing practices, such as local regulatory, cGMP requirements and ISO standards.
• Knowledge of Quality Management System processes and techniques.
• Knowledge of internal audit processes and techniques.
• Project Management and Risk Management experience: methodologies, techniques, tools and applications.
• Analysis and Reporting skills: methodologies, techniques, tools and applications.

About Us

We are a dynamic organization with great customers and a culture where people are valued and empowered to deliver amazing results. We are also growing and looking to hire talented and passionate individuals to join our team!

Seniority level

• Entry level

Employment type

• Full‑time

Job function

• Quality Assurance

Industries

• Pharmaceutical Manufacturing

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